Device product
VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Z-1648-2014
Product summary
- Event
- Event 67643
- Status
- Terminated
- Classification
- Class II
- Quantity
- 583 units Total (357 units domestically & 226 units internationally)
- Official record key
device-enforcement:Z-1648-2014
Official wording
Reason: Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.
Code information: Catalog Number: 139 3396, Lot Number: 1590
Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.
Derived failure modes
-
Unknown
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.